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    Methods

    NICE identified studies and reviews relevant to daytime intraoral neuromuscular electrical tongue stimulation using a removable device for obstructive sleep apnoea from the medical literature. The following databases were searched between the date they started to 28 June 2022: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the internet were also searched (see the literature search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

    The following inclusion criteria were applied to the abstracts identified by the literature search.

    • Publication type: clinical studies were included with emphasis on identifying good quality studies. Abstracts were excluded if they did not report clinical outcomes. Reviews, editorials, and laboratory or animal studies, were also excluded and so were conference abstracts, because of the difficulty of appraising study methodology, unless they reported specific adverse events that not available in the published literature.

    • Patients with obstructive sleep apnoea who are 18 or older.

    • Intervention or test: daytime intraoral neuromuscular electrical stimulation using a removable device.

    • Outcome: articles were retrieved if the abstract contained information relevant to the safety, efficacy, or both.

    If selection criteria could not be determined from the abstracts the full paper was retrieved.

    Potentially relevant studies not included in the main evidence summary are listed in the section on other relevant studies.

    Find out more about how NICE selects the evidence for the committee.

    Table 4 literature search strategy

    Databases

    Date searched

    Version/files

    MEDLINE (Ovid)

    29/06/22

    1946 to June 28, 2022

    MEDLINE In-Process (Ovid)

    29/06/22

    1946 to June 28, 2022

    MEDLINE Epubs ahead of print (Ovid)

    29/06/22

    June 28, 2022

    EMBASE (Ovid)

    29/06/22

    1974 to June 28, 2022

    EMBASE Conference (Ovid)

    29/06/22

    1974 to June 28, 2022

    Cochrane Database of Systematic Reviews – CDSR (Cochrane Library)

    29/06/22

    Issue 6 of 12, June 2022

    Cochrane Central Database of Controlled Trials – CENTRAL (Cochrane Library)

    29/06/22

    Issue 6 of 12, June 2022

    International HTA database (INAHTA)

    29/06/22

    -

    Trial sources searched

    • Clinicaltrials.gov

    • ISRCTN

    • WHO International Clinical Trials Registry

    Websites searched

    • National Institute for Health and Care Excellence (NICE)

    • NHS England

    • Food and Drug Administration (FDA) - MAUDE database

    • Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP – S)

    • Australia and New Zealand Horizon Scanning Network (ANZHSN)

    • General internet search

    The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases.

    MEDLINE search strategy

    1 Electric Stimulation Therapy/

    2 (Elect* adj4 stimulat* adj4 therap*).tw.

    3 Electrotherap*.tw.

    4 or/1-3

    5 (neurostimulat* or neuromuscular*).tw.

    6 NMES.tw.

    7 or/5-6

    8 4 and 7

    9 exp Sleep Apnea Syndromes/

    10 Sleep apn?ea.tw.

    11 Dyspnea/

    12 Dyspn?ea.tw.

    13 Cheyne-Stokes Respiration/

    14 (Cheyne-Stokes adj4 (Respiration or breath*)).tw.

    15 exp Sleep Wake Disorders/

    16 (sleep* adj4 disorder*).tw.

    17 Snoring/

    18 snoring*.tw.

    19 exp "Disorders of Excessive Somnolence"/

    20 (Daytime adj4 sleepiness adj4 disorder*).tw.

    21 ((Somnolence* or Hypersomnolence* or Hypersomnia*) adj4 disorder*).tw.

    22 or/9-21

    23 8 and 22

    24 ((Intraoral or preamendment) adj4 (device* or daytime* or remov*)).tw.

    25 22 and 24

    26 8 and 24

    27 eXciteOSA.tw.

    28 Snoozeal.tw.

    29 or/25-28

    30 23 or 29

    31 Animals/ not Humans

    32 30 not 31